Senior Utilities Engineer — GMP Biopharma Operations

Amgen; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible time-off plans

Career development opportunities

Job summary

Amgen in North Carolina is seeking a Clean Utilities Sr. Engineer to join the Facilities & Engineering group. You will own and optimize utility systems, support design, startup, qualification, and maintenance to sustain GMP operations in drug substance production.

The role requires a strong engineering background, GMP knowledge, and ability to lead improvements, perform RCA, and coordinate with operations and regulators. On-site with 24/7 support, travel as needed.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering or higher.
• 4+ years in Biopharmaceutical operations/manufacturing or similar.
• Experience with GMP Biopharmaceutical Production facility utilities.

Responsibilities

• Provide system ownership for Clean and Plant Utility systems.
• Design, construct, start-up, commissioning and qualification of new/modified systems.
• Develop maintenance programs and ensure spare parts availability.
• Ensure safety and environmental compliance and GMP alignment.
• Lead or participate in root cause analysis and CAPA.

Skills

Engineering leadership

GMP knowledge

Root cause analysis

Data analytics

Problem solving

Education

Bachelor’s degree in Chemical/Mechanical/Electrical Engineering

Tools

Plant Utility systems operation

Quality systems (cGMP, change control)

Job description

Amgen in North Carolina is seeking a Clean Utilities Sr. Engineer to join the Facilities & Engineering group. You will own and optimize utility systems, support design, startup, qualification, and maintenance to sustain GMP operations in drug substance production.

The role requires a strong engineering background, GMP knowledge, and ability to lead improvements, perform RCA, and coordinate with operations and regulators. On-site with 24/7 support, travel as needed.